Identity
- Trade Name
- Lapsingle Vision EUDAMED
- Device Name
- Lapsingle Vision EUDAMED
- Model / Reference
- LS-52-1313 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806182201141 EUDAMED
- Basic UDI-DI
- B-08806182201141 EUDAMED
- EMDN Code
- K01020106 MINIMALLY INVASIVE SURGERY SPREADERS AND RETRACTORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Lapsingle Vision by Sejong Medical Co., Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08806182201141 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SEJONG MEDICAL Co., Ltd.
- EUDAMED SRN
- KR-MF-000020090
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED c22cb653-779b-4e1e-9e97-506ca9a553c0 61 fields · synced Jul 27, 2026